Skip to content

Infinity Explorer

by Siemens Medical Solutions USA, Inc. 2 variants

510(k) K013515

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013515 Date10 Jan 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXJ
Device class
Class II
Regulation
21 CFR Part 870.2450
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Infinity Explorer is a software-driven critical care workstation that displays real-time physiological parameters and alarm data from Infinity modular monitors (SC 7000, 8000, 9000XL) and integrates DICOM images from hospital information systems. It is designed to extend the viewing capability of these monitors and consolidate patient information on a single display.

The device is supplied as a software application intended for use with commercially available patient vicinity computers. It received FDA 510(k) clearance (K013515) on January 10, 2002, and is classified as a Class II medical device under regulation number 870.2450 with product code DXJ. The device is used in cardiovascular care settings as indicated by the advisory committee classification.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Infinity Explorer used for?

    The Infinity Explorer is a software-driven critical care workstation designed to display real-time physiological parameters and alarm data from Infinity modular monitors (SC 7000, 8000, 9000XL) and integrate DICOM images from hospital information systems, extending viewing capability and consolidating patient information on a single display in cardiovascular care settings.

  • How is the Infinity Explorer supplied and what hardware is required?

    The Infinity Explorer is supplied as a software application intended for use with commercially available patient vicinity computers, meaning it requires standard computer hardware in the clinical environment to operate and is not provided with dedicated hardware.

  • Is the Infinity Explorer a single-use or reusable device?

    As a software application, the Infinity Explorer is reusable; it can be installed and used repeatedly on compatible computers without degradation from use, and there is no indication of single-use limitations in the provided data.

  • What regulatory pathway was used for the Infinity Explorer?

    The Infinity Explorer received FDA 510(k) clearance (K013515) on January 10, 2002, through a traditional submission pathway, and was found substantially equivalent to a predicate device.

  • What classification and product code apply to the Infinity Explorer?

    The Infinity Explorer is classified as a Class II medical device under regulation number 870.2450 with product code DXJ, as indicated in its FDA 510(k) clearance documentation.